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CandyCollect Strep Throat Testing

NCT05175196 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-04-13

No results posted yet for this study

Summary

This study will enroll children ages 5-17 who test positive for Group A Streptococcus (GAS) at a single clinic visit lasting approximately 30-60 minutes. The primary aim of this study is to assess the accuracy and feasibility of the CandyCollect platform to capture and detect GAS. The investigators hypothesize that the CandyCollect platform is non-inferior to gold-standard rapid antigen detection testing for GAS.

Conditions

  • Group A Streptococcal Infection

Interventions

DIAGNOSTIC_TEST

CandyCollect

The CandyCollect device is a novel, micro-engineered, lollipop-inspired platform. It has functionalized open microchannels for pathogen capture and concentration. It also has time-controlled flavoring release to make the platform more patient-centric.

DIAGNOSTIC_TEST

Lollipop Swab

The "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Child participants are instructed to suck on the swab for 10 seconds, as they would suck on a lollipop. Participant will be asked to take this test twice.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Gregory DeMuri, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175196 on ClinicalTrials.gov